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Nical Smart Micro NPR System

by Nical SpA 7 variants

Nical Smart Micro NPR System (NSM1001US) is a Class II device made by Nical SpA, cleared under FDA 510(k) K143703 on 18 Mar 2015 and listed in FDA GUDID since 28 Sep 2023 (UDI-DI 08056600520013), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K143703

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08056600520013 UDI-DI Date28 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143703 Date18 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143703 decided 18 Mar 2015 Active
  • FDA GUDID UDI-DI 08056600520013 listed 28 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K143703
  2. Listed FDA GUDID 08056600520013

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nical Smart Micro
Generic name
Dental computed radiography digital imaging scanner
Model / Ref / Catalog
NPR System, NSM1001US
Primary DI / UDI-DI
08056600520013
510(k) Number
FDA product code
MUH
GMDN term
Dental computed radiography digital imaging scanner
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

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Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)